STAT+: FDA refuses to review Moderna\u2019s influenza vaccine
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The Food and Drug Administration refused to review Moderna\u2019s application for a new influenza vaccine, the company said Tuesday, a surprise decision that could\u00a0 raise concerns about the agency\u2019s posture toward drug companies and the Trump administration\u2019s policies on vaccines.<\/p>\n
Moderna, revealing the rejection, took the unusual step of releasing the letter that it had received from Vinay Prasad, <\/a>who heads FDA\u2019s biologics division, and issued a strongly worded statement from its CEO, Stephane Bancel, saying the decision \u201cdoes not further our shared goal of enhancing America\u2019s leadership in developing innovative medicines.\u201d<\/p>\n At the heart of the dispute is what existing influenza vaccine Moderna should have used as a control when testing the efficacy of its new shot, which utilizes the same mRNA technology the company\u2019s used in its Covid-19 vaccine\u00a0<\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n